What went wrong in Bharat Biotech's Covaxin deal with Brazil? All you need to know...
What went wrong in Bharat Biotech's Covaxin deal with Brazil? All you need to know...
Hyderabad-based Bharat Biotech on Friday cancelled its agreement with two firms for the supply of Covaxin as the Brazilian government had cancelled the deal following graft allegations.
On Saturday, Brazil suspended the proposed clinical studies that the Indian vaccine maker was about to undertake in the country. This all happened in a chain reaction after the Brazilian government suspended its deal with Bharat Biotech to procure 20 million doses of Covaxin.
In November 2020, Bharat Biotech entered into an agreement with Precisa Medicamentos and Envixia Pharmaceuticals LL.C. Precisa, Bharat biotech's partner providing assistance, guidance, and support with regulatory submissions, licensure, distribution, insurance and conduct of phase III clinical trials, among others.
Since Precisa was representing Bharat Biotech in Brazil so far and will not do so from now on, the clinical trial has to be suspended naturally.
Graft allegation or partnership problem?
The Bolsonaro government faced allegations of corruption regarding its agreement with Bharat Biotech which is still under investigation. Whistleblowers from Brazil's health department said there was pressure from higher authorities regarding the Bharat Biotech deal. It was also alleged that Pfizer was giving vaccines to Brazil at a cheaper rate. Following this, the deal was cancelled and the Brazilian government said that there was no corruption as no money was paid to Bharat Biotech. Bharat Biotech also confirmed that it has neither received any advance payment from the Brazilian government nor supplied any vaccine.
Precisa is a Brazil-based firm while Envixia is registered in Dubai.
As Bharat Biotech has now distanced it from these two firms, it has also brought some allegations without pointing any finger to any firm particularly. "We have recently been informed that certain letters purported to have been executed by executive of the company are being circulated online. We would like to emphatically state that these documents have not been issued by the company or its executives and therefore vehemently deny the same," Bharat Biotech said in the statement, issued on Friday.
What now? Is Covaxin approved in Brazil?
When the deal was on, it was claimed that Bharat Biotech's Covaxin received approval from Brazil's health regulator Anvisa on June 4. But later it was clarified that on June 4 Anvisa authorised exceptional import of Covaxin vaccine by the ministry of health for distribution and use under controller conditions.
Now that the deal stands cancelled, Bharat Biotech said it will work with Anvisa diligently to complete the regulatory approval process.
"There are two processes of the company related to the regularisation of Covaxin in Brazil- an application for authorisation for emergency use and a protocol for conducting clinical research in that country. Based on the communication made by Bharat Biotech, Anvisa will reassess the processes underway at the Agency and adopt the relevant measures," Brazil's health regulator said, as quoted by news agency PTI.
